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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00038 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy.
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis.
This compound has been shown to be superior to choline based PET agents for the staging of prostate cancer, both Carbon-11 and Fluorine-18 compounds. But this compound was not patented and therefore no company or private entity will make the investment required to bring Ga-68-PSMA-11 to market. In the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future FDA approval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ga-68 labeled PSMA-11 PET | Experimental | PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ga-68 labeled PSMA-11 PET | Drug | Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy | Sensitivity is defined as the ratio of the proportion of the patients who have the condition of interest and whose test results are positive over the number who have the disease. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true-negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for up to one year can be used in analysis | Up to 1 year |
| Specificity of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy | Specificity is defined as the number of non-diseased participants correctly classified divided by all non-diseased individuals. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true-negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for up to one year can be used in analysis | Up to 1 year |
| Positive Predictive Value (PPV) of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy | PPV is the proportion of patients with positive test who actually have the disease. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true-negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for up to one year can be used in analysis | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3 Treatment-related Adverse Events | All grade 3 and above adverse events were recorded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The Investigator assigns grade, attribution of the possible association of the event with use of the investigational drug. The safety parameters include spontaneous reports of adverse events reported to the investigator by patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Hope, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37482512 | Derived | Djaileb L, Armstrong WR, Thompson D, Gafita A, Farolfi A, Rajagopal A, Grogan TR, Nguyen K, Benz MR, Hotta M, Barbato F, Ceci F, Schwarzenbock SM, Unterrainer M, Zacho HD, Juarez R, Cooperberg M, Carroll P, Washington S, Reiter RE, Eiber M, Herrmann K, Fendler WP, Czernin J, Hope TA, Calais J. Presurgical 68Ga-PSMA-11 Positron Emission Tomography for Biochemical Recurrence Risk Assessment: A Follow-up Analysis of a Multicenter Prospective Phase 3 Imaging Trial. Eur Urol. 2023 Dec;84(6):588-596. doi: 10.1016/j.eururo.2023.06.022. Epub 2023 Jul 21. | |
| 34529005 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ga-68 Labeled PSMA-11 PET | PSMA Positron Emission Tomography (PET) imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ga-68 Labeled PSMA-11 PET | PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy | Sensitivity is defined as the ratio of the proportion of the patients who have the condition of interest and whose test results are positive over the number who have the disease. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true-negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for up to one year can be used in analysis | Posted | Number | proportion of participants | Up to 1 year |
|
Up to 3 days
All grade 3 and above adverse events were reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ga-68 Labeled PSMA-11 PET | PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Hope, MD | University of California, San Francisco | (415) 221-4810 | 22648 | Thomas.Hope@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2018 | Oct 19, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2017 | Oct 19, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
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|
| Negative Predictive Value (NPV) of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy | NPV is the ratio of participants truly diagnosed as negative to all those who had negative test results. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for obtained up to one year after study scan be used in analysis. | Up to 1 year |
| Up to 3 days |
| Sensitivity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases | Gallium 68 labeled PSMA-11 (68Ga-PSMA-11) positive lymph nodes will be considered for detection of extra-pelvic nodal metastases and assessed by change in size. Participants who if on follow-up imaging within 3-12 months, have lymph nodes which decrease by more than 30% or increase by more than 20% in short axis diameter (with a minimum of 3 mm in change in size) or with solitary lymph node regions show a decrease of Prostate-specific antigen (PSA) by >50% after targeted treatment and the lymph nodes do not change in size (less than 30% decrease or less than 20% increase in short axis diameter) will be counted as true positives. If on follow-up imaging, sites of initial 68Ga-PSMA-11 positive lymph node lesions < 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive lymph node lesions that do not meet criteria for above false positive or true positive will be counted as false positives. | Up to 1 year |
| Specificity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases | 68Ga-PSMA-11 positive lymph nodes will be considered for detection of extra-pelvic nodal metastases and assessed by change in size. Participants who if on follow-up imaging within 3-12 months, have lymph nodes which decrease by more than 30% or increase by more than 20% in short axis diameter (with a minimum of 3 mm in change in size) or with solitary lymph node regions show a decrease of PSA by >50% after targeted treatment and the lymph nodes do not change in size (less than 30% decrease or less than 20% increase in short axis diameter) will be counted as true positives. If on follow-up imaging, sites of initial 68Ga-PSMA-11 positive lymph node lesions < 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive lymph node lesions that do not meet criteria for above false positive or true positive will be counted as false positives. | Up to 1 year |
| Positive Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases | 68Ga-PSMA-11 positive lymph nodes will be considered for detection of extra-pelvic nodal metastases and assessed by change in size. Participants who if on follow-up imaging within 3-12 months, have lymph nodes which decrease by more than 30% or increase by more than 20% in short axis diameter (with a minimum of 3 mm in change in size) or with solitary lymph node regions show a decrease of PSA by >50% after targeted treatment and the lymph nodes do not change in size (less than 30% decrease or less than 20% increase in short axis diameter) will be counted as true positives. If on follow-up imaging, sites of initial 68Ga-PSMA-11 positive lymph node lesions < 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive lymph node lesions that do not meet criteria for above false positive or true positive will be counted as false positives. | Up to 1 year |
| Negative Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases | 68Ga-PSMA-11 positive lymph nodes will be considered for detection of extra-pelvic nodal metastases and assessed by change in size. Participants who if on follow-up imaging within 3-12 months, have lymph nodes which decrease by more than 30% or increase by more than 20% in short axis diameter (with a minimum of 3 mm in change in size) or with solitary lymph node regions show a decrease of PSA by >50% after targeted treatment and the lymph nodes do not change in size (less than 30% decrease or less than 20% increase in short axis diameter) will be counted as true positives. If on follow-up imaging, sites of initial 68Ga-PSMA-11 positive lymph node lesions < 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive lymph node lesions that do not meet criteria for above false positive or true positive will be counted as false positives. | Up to 1 year |
| Sensitivity of PSMA PET for the Detection of Visceral Metastases | Visceral lesions (non-lymph node soft tissue or organ) will be assessed by change in size. 68Ga-PSMA-11 positive visceral lesions will be considered True positive if on follow-up imaging within 3-12 months, visceral lesions seen on imaging decrease by 30% (for patients undergoing systemic treatment of focal therapy at this site) or increase by 20% in largest diameter or if participants with solitary visceral metastasis show a decrease of PSA by greater than 50% after targeted treatment and lesions do not change in size (less than 30% decrease or 20% increase in largest diameter) and False positive if on follow-up imaging within 3-12 months, sites of initial 68Ga-PSMA-11 positive visceral lesions seen on CT or MRI decrease by more than 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive visceral lesions do not meet the criteria for above false positive or true positive findings. | Up to 1 year |
| Specificity of PSMA PET for the Detection of Visceral Metastases | Visceral lesions (non-lymph node soft tissue or organ) will be assessed by change in size. 68Ga-PSMA-11 positive visceral lesions will be considered True positive if on follow-up imaging within 3-12 months, visceral lesions seen on imaging decrease by 30% (for patients undergoing systemic treatment of focal therapy at this site) or increase by 20% in largest diameter or if participants with solitary visceral metastasis show a decrease of PSA by greater than 50% after targeted treatment and lesions do not change in size (less than 30% decrease or 20% increase in largest diameter) and False positive if on follow-up imaging within 3-12 months, sites of initial 68Ga-PSMA-11 positive visceral lesions seen on CT or MRI decrease by more than 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive visceral lesions do not meet the criteria for above false positive or true positive findings. | Up to 1 year |
| Positive Predictive Value of PSMA PET Visceral Metastases | Visceral lesions (non-lymph node soft tissue or organ) will be assessed by change in size. 68Ga-PSMA-11 positive visceral lesions will be considered True positive if on follow-up imaging within 3-12 months, visceral lesions seen on imaging decrease by 30% (for patients undergoing systemic treatment of focal therapy at this site) or increase by 20% in largest diameter or if participants with solitary visceral metastasis show a decrease of PSA by greater than 50% after targeted treatment and lesions do not change in size (less than 30% decrease or 20% increase in largest diameter) and False positive if on follow-up imaging within 3-12 months, sites of initial 68Ga-PSMA-11 positive visceral lesions seen on CT or MRI decrease by more than 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive visceral lesions do not meet the criteria for above false positive or true positive findings. | Up to 1 year |
| Negative Predictive Value of PSMA PET for the Detection of Visceral Metastases | Visceral lesions (non-lymph node soft tissue or organ) will be assessed by change in size. 68Ga-PSMA-11 positive visceral lesions will be considered True positive if on follow-up imaging within 3-12 months, visceral lesions seen on imaging decrease by 30% (for patients undergoing systemic treatment of focal therapy at this site) or increase by 20% in largest diameter or if participants with solitary visceral metastasis show a decrease of PSA by greater than 50% after targeted treatment and lesions do not change in size (less than 30% decrease or 20% increase in largest diameter) and False positive if on follow-up imaging within 3-12 months, sites of initial 68Ga-PSMA-11 positive visceral lesions seen on CT or MRI decrease by more than 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive visceral lesions do not meet the criteria for above false positive or true positive findings. | Up to 1 year |
| Sensitivity of PSMA PET for the Detection of Osseous Metastases | 68Ga-PSMA-11 positive bone lesions will be considered a True positive if there was a corresponding positive sclerotic lesion on the CT portion of the 68Ga-PSMA-11 PET in the same location as the PSMA uptake, If there is focal uptake seen in the same location as the PSMA uptake on the baseline bone scan performed within one month of 68Ga-PSMA-11 PET, if there is a lesion noted in the same location as the PSMA uptake on the initial MRI performed within one month of 68Ga-PSMA-11 PET, if within 12 months follow-up CT demonstrates development of sclerosis in the same location as the PSMA uptake, if within 12 months follow-up MRI demonstrates a new bone lesion in the same location as the PSMA uptake, if within 12 months follow-up bone scan demonstrates new focal uptake in the same location as the PSMA uptake and a False positive if 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true positive findings. | Up to 1 year |
| Specificity of PSMA PET for the Detection of Osseous Metastases | 68Ga-PSMA-11 positive bone lesions will be considered a True positive if there was a corresponding positive sclerotic lesion on the CT portion of the 68Ga-PSMA-11 PET in the same location as the PSMA uptake, If there is focal uptake seen in the same location as the PSMA uptake on the baseline bone scan performed within one month of 68Ga-PSMA-11 PET, if there is a lesion noted in the same location as the PSMA uptake on the initial MRI performed within one month of 68Ga-PSMA-11 PET, if within 12 months follow-up CT demonstrates development of sclerosis in the same location as the PSMA uptake, if within 12 months follow-up MRI demonstrates a new bone lesion in the same location as the PSMA uptake, if within 12 months follow-up bone scan demonstrates new focal uptake in the same location as the PSMA uptake and a False positive if 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true positive findings. | Up to 1 year |
| Positive Predictive Value of PSMA PET for the Detection of Osseous Metastases | 68Ga-PSMA-11 positive bone lesions will be considered a True positive if there was a corresponding positive sclerotic lesion on the CT portion of the 68Ga-PSMA-11 PET in the same location as the PSMA uptake, If there is focal uptake seen in the same location as the PSMA uptake on the baseline bone scan performed within one month of 68Ga-PSMA-11 PET, if there is a lesion noted in the same location as the PSMA uptake on the initial MRI performed within one month of 68Ga-PSMA-11 PET, if within 12 months follow-up CT demonstrates development of sclerosis in the same location as the PSMA uptake, if within 12 months follow-up MRI demonstrates a new bone lesion in the same location as the PSMA uptake, if within 12 months follow-up bone scan demonstrates new focal uptake in the same location as the PSMA uptake and a False positive if 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true positive findings. | Up to 1 year |
| Negative Predictive Value of PSMA PET for the Detection of Osseous Metastases | 68Ga-PSMA-11 positive bone lesions will be considered a True positive if there was a corresponding positive sclerotic lesion on the CT portion of the 68Ga-PSMA-11 PET in the same location as the PSMA uptake, If there is focal uptake seen in the same location as the PSMA uptake on the baseline bone scan performed within one month of 68Ga-PSMA-11 PET, if there is a lesion noted in the same location as the PSMA uptake on the initial MRI performed within one month of 68Ga-PSMA-11 PET, if within 12 months follow-up CT demonstrates development of sclerosis in the same location as the PSMA uptake, if within 12 months follow-up MRI demonstrates a new bone lesion in the same location as the PSMA uptake, if within 12 months follow-up bone scan demonstrates new focal uptake in the same location as the PSMA uptake and a False positive if 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true positive findings. | Up to 1 year |
| Derived |
| Hope TA, Eiber M, Armstrong WR, Juarez R, Murthy V, Lawhn-Heath C, Behr SC, Zhang L, Barbato F, Ceci F, Farolfi A, Schwarzenbock SM, Unterrainer M, Zacho HD, Nguyen HG, Cooperberg MR, Carroll PR, Reiter RE, Holden S, Herrmann K, Zhu S, Fendler WP, Czernin J, Calais J. Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial. JAMA Oncol. 2021 Nov 1;7(11):1635-1642. doi: 10.1001/jamaoncol.2021.3771. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Specificity of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy | Specificity is defined as the number of non-diseased participants correctly classified divided by all non-diseased individuals. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true-negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for up to one year can be used in analysis | Posted | Number | proportion of participants | Up to 1 year |
|
|
|
| Primary | Positive Predictive Value (PPV) of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy | PPV is the proportion of patients with positive test who actually have the disease. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true-negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for up to one year can be used in analysis | Posted | Number | proportion of true positives | Up to 1 year |
|
|
|
| Primary | Negative Predictive Value (NPV) of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy | NPV is the ratio of participants truly diagnosed as negative to all those who had negative test results. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for obtained up to one year after study scan be used in analysis. | Posted | Number | proportion of true negatives | Up to 1 year |
|
|
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| Secondary | Number of Participants With Grade 3 Treatment-related Adverse Events | All grade 3 and above adverse events were recorded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The Investigator assigns grade, attribution of the possible association of the event with use of the investigational drug. The safety parameters include spontaneous reports of adverse events reported to the investigator by patients | Posted | Count of Participants | Participants | Up to 3 days |
|
|
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| Secondary | Sensitivity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases | Gallium 68 labeled PSMA-11 (68Ga-PSMA-11) positive lymph nodes will be considered for detection of extra-pelvic nodal metastases and assessed by change in size. Participants who if on follow-up imaging within 3-12 months, have lymph nodes which decrease by more than 30% or increase by more than 20% in short axis diameter (with a minimum of 3 mm in change in size) or with solitary lymph node regions show a decrease of Prostate-specific antigen (PSA) by >50% after targeted treatment and the lymph nodes do not change in size (less than 30% decrease or less than 20% increase in short axis diameter) will be counted as true positives. If on follow-up imaging, sites of initial 68Ga-PSMA-11 positive lymph node lesions < 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive lymph node lesions that do not meet criteria for above false positive or true positive will be counted as false positives. | Data on the detection of extra-pelvic nodal metastases was not collected | Posted | Up to 1 year |
|
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| Secondary | Specificity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases | 68Ga-PSMA-11 positive lymph nodes will be considered for detection of extra-pelvic nodal metastases and assessed by change in size. Participants who if on follow-up imaging within 3-12 months, have lymph nodes which decrease by more than 30% or increase by more than 20% in short axis diameter (with a minimum of 3 mm in change in size) or with solitary lymph node regions show a decrease of PSA by >50% after targeted treatment and the lymph nodes do not change in size (less than 30% decrease or less than 20% increase in short axis diameter) will be counted as true positives. If on follow-up imaging, sites of initial 68Ga-PSMA-11 positive lymph node lesions < 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive lymph node lesions that do not meet criteria for above false positive or true positive will be counted as false positives. | Data on the detection of extra-pelvic nodal metastases was not collected | Posted | Up to 1 year |
|
|
| Secondary | Positive Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases | 68Ga-PSMA-11 positive lymph nodes will be considered for detection of extra-pelvic nodal metastases and assessed by change in size. Participants who if on follow-up imaging within 3-12 months, have lymph nodes which decrease by more than 30% or increase by more than 20% in short axis diameter (with a minimum of 3 mm in change in size) or with solitary lymph node regions show a decrease of PSA by >50% after targeted treatment and the lymph nodes do not change in size (less than 30% decrease or less than 20% increase in short axis diameter) will be counted as true positives. If on follow-up imaging, sites of initial 68Ga-PSMA-11 positive lymph node lesions < 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive lymph node lesions that do not meet criteria for above false positive or true positive will be counted as false positives. | Data on the detection of extra-pelvic nodal metastases was not collected | Posted | Up to 1 year |
|
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| Secondary | Negative Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases | 68Ga-PSMA-11 positive lymph nodes will be considered for detection of extra-pelvic nodal metastases and assessed by change in size. Participants who if on follow-up imaging within 3-12 months, have lymph nodes which decrease by more than 30% or increase by more than 20% in short axis diameter (with a minimum of 3 mm in change in size) or with solitary lymph node regions show a decrease of PSA by >50% after targeted treatment and the lymph nodes do not change in size (less than 30% decrease or less than 20% increase in short axis diameter) will be counted as true positives. If on follow-up imaging, sites of initial 68Ga-PSMA-11 positive lymph node lesions < 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive lymph node lesions that do not meet criteria for above false positive or true positive will be counted as false positives. | Data on the detection of extra-pelvic nodal metastases was not collected | Posted | Up to 1 year |
|
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| Secondary | Sensitivity of PSMA PET for the Detection of Visceral Metastases | Visceral lesions (non-lymph node soft tissue or organ) will be assessed by change in size. 68Ga-PSMA-11 positive visceral lesions will be considered True positive if on follow-up imaging within 3-12 months, visceral lesions seen on imaging decrease by 30% (for patients undergoing systemic treatment of focal therapy at this site) or increase by 20% in largest diameter or if participants with solitary visceral metastasis show a decrease of PSA by greater than 50% after targeted treatment and lesions do not change in size (less than 30% decrease or 20% increase in largest diameter) and False positive if on follow-up imaging within 3-12 months, sites of initial 68Ga-PSMA-11 positive visceral lesions seen on CT or MRI decrease by more than 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive visceral lesions do not meet the criteria for above false positive or true positive findings. | Data on the detection of visceral metastases was not collected | Posted | Up to 1 year |
|
|
| Secondary | Specificity of PSMA PET for the Detection of Visceral Metastases | Visceral lesions (non-lymph node soft tissue or organ) will be assessed by change in size. 68Ga-PSMA-11 positive visceral lesions will be considered True positive if on follow-up imaging within 3-12 months, visceral lesions seen on imaging decrease by 30% (for patients undergoing systemic treatment of focal therapy at this site) or increase by 20% in largest diameter or if participants with solitary visceral metastasis show a decrease of PSA by greater than 50% after targeted treatment and lesions do not change in size (less than 30% decrease or 20% increase in largest diameter) and False positive if on follow-up imaging within 3-12 months, sites of initial 68Ga-PSMA-11 positive visceral lesions seen on CT or MRI decrease by more than 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive visceral lesions do not meet the criteria for above false positive or true positive findings. | Data on the detection of visceral metastases was not collected | Posted | Up to 1 year |
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| Secondary | Positive Predictive Value of PSMA PET Visceral Metastases | Visceral lesions (non-lymph node soft tissue or organ) will be assessed by change in size. 68Ga-PSMA-11 positive visceral lesions will be considered True positive if on follow-up imaging within 3-12 months, visceral lesions seen on imaging decrease by 30% (for patients undergoing systemic treatment of focal therapy at this site) or increase by 20% in largest diameter or if participants with solitary visceral metastasis show a decrease of PSA by greater than 50% after targeted treatment and lesions do not change in size (less than 30% decrease or 20% increase in largest diameter) and False positive if on follow-up imaging within 3-12 months, sites of initial 68Ga-PSMA-11 positive visceral lesions seen on CT or MRI decrease by more than 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive visceral lesions do not meet the criteria for above false positive or true positive findings. | Data on the detection of visceral metastases was not collected | Posted | Up to 1 year |
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| Secondary | Negative Predictive Value of PSMA PET for the Detection of Visceral Metastases | Visceral lesions (non-lymph node soft tissue or organ) will be assessed by change in size. 68Ga-PSMA-11 positive visceral lesions will be considered True positive if on follow-up imaging within 3-12 months, visceral lesions seen on imaging decrease by 30% (for patients undergoing systemic treatment of focal therapy at this site) or increase by 20% in largest diameter or if participants with solitary visceral metastasis show a decrease of PSA by greater than 50% after targeted treatment and lesions do not change in size (less than 30% decrease or 20% increase in largest diameter) and False positive if on follow-up imaging within 3-12 months, sites of initial 68Ga-PSMA-11 positive visceral lesions seen on CT or MRI decrease by more than 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive visceral lesions do not meet the criteria for above false positive or true positive findings. | Data on the detection of visceral metastases was not collected | Posted | Up to 1 year |
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| Secondary | Sensitivity of PSMA PET for the Detection of Osseous Metastases | 68Ga-PSMA-11 positive bone lesions will be considered a True positive if there was a corresponding positive sclerotic lesion on the CT portion of the 68Ga-PSMA-11 PET in the same location as the PSMA uptake, If there is focal uptake seen in the same location as the PSMA uptake on the baseline bone scan performed within one month of 68Ga-PSMA-11 PET, if there is a lesion noted in the same location as the PSMA uptake on the initial MRI performed within one month of 68Ga-PSMA-11 PET, if within 12 months follow-up CT demonstrates development of sclerosis in the same location as the PSMA uptake, if within 12 months follow-up MRI demonstrates a new bone lesion in the same location as the PSMA uptake, if within 12 months follow-up bone scan demonstrates new focal uptake in the same location as the PSMA uptake and a False positive if 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true positive findings. | Data on the detection of osseous metastases was not collected | Posted | Up to 1 year |
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| Secondary | Specificity of PSMA PET for the Detection of Osseous Metastases | 68Ga-PSMA-11 positive bone lesions will be considered a True positive if there was a corresponding positive sclerotic lesion on the CT portion of the 68Ga-PSMA-11 PET in the same location as the PSMA uptake, If there is focal uptake seen in the same location as the PSMA uptake on the baseline bone scan performed within one month of 68Ga-PSMA-11 PET, if there is a lesion noted in the same location as the PSMA uptake on the initial MRI performed within one month of 68Ga-PSMA-11 PET, if within 12 months follow-up CT demonstrates development of sclerosis in the same location as the PSMA uptake, if within 12 months follow-up MRI demonstrates a new bone lesion in the same location as the PSMA uptake, if within 12 months follow-up bone scan demonstrates new focal uptake in the same location as the PSMA uptake and a False positive if 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true positive findings. | Data on the detection of osseous metastases was not collected | Posted | Up to 1 year |
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| Secondary | Positive Predictive Value of PSMA PET for the Detection of Osseous Metastases | 68Ga-PSMA-11 positive bone lesions will be considered a True positive if there was a corresponding positive sclerotic lesion on the CT portion of the 68Ga-PSMA-11 PET in the same location as the PSMA uptake, If there is focal uptake seen in the same location as the PSMA uptake on the baseline bone scan performed within one month of 68Ga-PSMA-11 PET, if there is a lesion noted in the same location as the PSMA uptake on the initial MRI performed within one month of 68Ga-PSMA-11 PET, if within 12 months follow-up CT demonstrates development of sclerosis in the same location as the PSMA uptake, if within 12 months follow-up MRI demonstrates a new bone lesion in the same location as the PSMA uptake, if within 12 months follow-up bone scan demonstrates new focal uptake in the same location as the PSMA uptake and a False positive if 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true positive findings. | Data on the detection of osseous metastases was not collected | Posted | Up to 1 year |
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| Secondary | Negative Predictive Value of PSMA PET for the Detection of Osseous Metastases | 68Ga-PSMA-11 positive bone lesions will be considered a True positive if there was a corresponding positive sclerotic lesion on the CT portion of the 68Ga-PSMA-11 PET in the same location as the PSMA uptake, If there is focal uptake seen in the same location as the PSMA uptake on the baseline bone scan performed within one month of 68Ga-PSMA-11 PET, if there is a lesion noted in the same location as the PSMA uptake on the initial MRI performed within one month of 68Ga-PSMA-11 PET, if within 12 months follow-up CT demonstrates development of sclerosis in the same location as the PSMA uptake, if within 12 months follow-up MRI demonstrates a new bone lesion in the same location as the PSMA uptake, if within 12 months follow-up bone scan demonstrates new focal uptake in the same location as the PSMA uptake and a False positive if 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true positive findings. | Data on the detection of osseous metastases was not collected | Posted | Up to 1 year |
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| 0 |
| 299 |
| 0 |
| 299 |
| 0 |
| 299 |
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |